OE SERIES OF BEHIND-THE-EAR HEARING AIDS— 510(k) K853381
Substantially EquivalentEmtech Laboratories
FDA 510(k) clearance K853381 for OE SERIES OF BEHIND-THE-EAR HEARING AIDS, Substantially Equivalent on 1985-11-08. Applicant: Emtech Laboratories. Device class: 1.
Clearance details
- Applicant
- Emtech Laboratories
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roanoke, VA, US
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